Genome & Company

Genome & Company

Contact

Genome & Company
B-8F Silicon Park, 35 Pangyo-ro 255beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea, 13486

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Consent to collection and use of personal information (Required)

Genome & Company (the ”Company”) regards the protection of personal information of our users very important, and complies with relevant laws, including the Personal Information Protection Act and the Act on Expansion of Dissemination and Promotion of Utilization of Information System. The Company hereby informs the purpose and method of using the personal information provided by our users through the Company’s website, and what measures are taken to protect the personal information. If the Company revises any of this Private Policy, it will be notified through the notices on the Company’s website (or individually notified).

1. Items of Personal Information Collected and the Collection Method

The Company collects the following personal information to operate its Contact Service via the Company’s website (whereby the users can make general inquires, inquiry for business development, IR inquiry, media inquiry, etc.).
- Essential Information: name, e-mail address, phone number, organization, content of inquiry
- Collection method: The Company collects the personal information through the inquiries submitted via the Contact Bulletin Board on the Company’s website.

  You have the right to refuse the ‘collection of essential information’ as well as the ‘collection of optional information’. If you refuse the collection of essential information, however, you may be restricted for using the Contact Service.

The following information may be automatically generated and collected in the process of using the website.
- IP Address, cookie, date and time of visit, records of service use

2. Purpose of Collecting Personal Information

The Company uses the collected personal information for the following purposes.
- Personal verification, personal identification, delivery of inquiries and notification of results (answers and responses), etc. related to the use of Contact Service

3. Processing of Personal Information and Retention Period

In principle, the collected personal information is destroyed without any delay after achieving the purpose of collecting and using personal information. However, the Company may keep users’ information for a certain period of time as required by relevant laws.
- Retained information: personal information submitted with the inquiry, content of the inquiry, and ensuing responses
- Relevant Law: Act on the Consumer Protection in Electronic Commerce, etc.
- Retention Period: three years (records related to resolution of consumer complaints or disputes)

4. Destruction of Personal Informatio

In principle, the information is destroyed without any delay after achieving the purpose of collecting and using personal information. The procedure and method of destruction are as follows.

1) Procedure
The personal information submitted is transferred to a separate database (in case of paper, separate cabinet) after achieving the purpose and kept for a certain period of time according to the internal policy and other relevant laws, before it is destroyed. The personal information transferred to separate database shall not be used any other purposes other than for keeping in accordance with laws.

  2) Destruction Method
Personal information saved in the form of electronic file shall be deleted by using technical method that cannot reproduce the records. Personal information printed in the paper shall be destroyed by shredding with a shredder or incinerating it.

5. Consignment of Personal Information Processing

The Company does not consign personal information to a third party. If consignment occurs in the future, it shall be notified through website and the contents of this Privacy Policy shall be updated.

6. Rights of Users and Their Legal Representatives

Users and their legal representative (for the users below the age of 14) may make an inquiry related to or request deletion or modification of their own personal information. In this case, please contact the Company’s Data Protection Manager (see Section 7 of this Privacy Policy) in writing, by phone, or by e-mail so that we can take measures without any delay after verifying your identification.

In case users request the correction of any errors in personal information, we shall not use or provide the personal information until such correction is made. In addition, in case incorrect personal information is already provided to a third party, we will notify the third party the result of correction without delay.

The Company processes and destroys personal information at the request of users or their legal representatives in accordance with Section ‘3. Processing of Personal Information and Retention Period’ and Section ‘4. Destruction of Personal Information’, and such information shall not be opened or used for any other purposes.

7. Information on Data Protection Officer and Manager

The Company designates data protection officer and manager for managing personal information as follows to protect users’ personal information related to inquiries.

Data Protection Officer
Name: Seo Yeong-jin
Department: Business management
Position: Vice-president
Telephone: 031-620-0150
Email: youngjin.seo@genomecom.co.kr

  Data Protection Manager
Name: Seol Su-gi
Department: PR team
Position: Team Lead
Telephone: 070-4821-3840
Email: sugi@genomecom.co.kr

You can submit to the personnel above any inquiries related to your personal information submitted to the Company while using our web service. The Company will quickly provide sufficient responses to your inquiries.

Please contact the below agencies if you need report or counseling for any infringement of personal data privacy.

- Personal Information Infringement Report Center (privacy.kisa.or.kr / 118 without area code)
- Personal Information Dispute Mediation Committee (kopico.go.kr / 1833-6972)
- Cyber Investigation Department, Supreme Prosecutor’s Office (www.spo.go.kr / 1301 without area code)
- Cyber Bureau of the National Police Agency (http://cyberbureau.police.go.kr / 182 without area code)

8. Notification

We will notify users any additions, deletions, and modification on the current Privacy Policy in advance through ‘Notice’ on the Company’s website.

9. Other Websites

We inform you that any collection of personal information by other websites which may be hyperlinked on the Company’s website is not the subject of this Privacy Policy.

Press Release

[Press Release] Genome and Company signs second clinical trial collabo…

Genome and Company signs second clinical trial collaboration and supply agreement (Phase 2)
with Merck
KGaA, Darmstadt, Germany and Pfizer
for immuno-oncology microbiome study


 

n  Genome and Company expands collaboration with Merck KGaA, Darmstadt, Germany and Pfizer for further clinical combination study of GEN-001 in gastric cancers

n  Establishment of the efficient “clinical development strategy” for the global immuno-oncology microbiome treatment

 

[Mar. 9, 2021] Genome and Company (KOSDAQ: 314130), a leading global microbiome anti-cancer drug development company, signed a second clinical trial collaboration and supply agreement (CTCSA) with Merck KGaA, Darmstadt, Germany and Pfizer Inc. with the aim of developing the world’s first immuno-oncology microbiome therapeutic. The collaboration follows in just a year after signing the first agreement with Merck KGaA, Darmstadt, Germany and Pfizer in December 2019 to conduct the first combination clinical trial of avelumab (BAVENCIO®) and GEN-001 (NCT04601402, “Study 101”).

 

The objective of the clinical trial (“Study 201”) under this newly entered CTCSA is to investigate the efficacy and safety of the combination of GEN-001 and avelumab for gastric and gastroesophageal junction adenocarcinoma that continue to be difficult to treat. This trial will be conducted simultaneously at six or more hospital and medical center sites in the Republic of Korea.

 

With this clinical trial, Genome and Company will proceed with Phase 2a to assess the efficacy and safety of the combination of GEN-001 and avelumab using the defined recommended phase 2 dose (RP2D) of GEN-001 in combination with avelumab. Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for use in the new company-led clinical trial, Study 201. The extended clinical collaboration between Genome and Company and Merck KGaA, Darmstadt, Germany and Pfizer marks the first time that two consecutive clinical development collaborations have been executed between combination partners for immuno-oncology microbiome treatment.

 

Genome and Company is developing GEN-001 through an efficient clinical development roadmap in cooperation with experts in the field. The company is leading clinical trials in systematic approaches to immediately advance to phase 2 upon the completion of a phase 1 study. Also, the company has achieved IND clearance by the US FDA and MFDS in the Republic of Korea for a variety of patient demographics as well as cancer types.

 

Dr. Jisoo Pae, CEO of Genome and Company, said, “This second CTCSA with Merck KGaA, Darmstadt, Germany and Pfizer is the achievement of our outstanding R&D capabilities and the effective clinical collaboration that is established through the ongoing Study 101. We would be able to reach the oncology leadership position using immuno-oncology microbiome treatment especially in the Asian market through the additional clinical trial.”

 

Under the terms of these agreements, Genome and Company will be the sponsor of the studies, and Merck KGaA, Darmstadt, Germany and Pfizer will supply avelumab for both Study 101 and Study 201. Both parties will have access to the clinical data.

 

[Image 1] Genome & Company CI

About Genome & Company

 

Since its establishment in 2015, Genome & Company develops next waves of innovative drugs including anti-cancer microbiome therapeutics and novel target immune checkpoint inhibitors. With the acquisition of Scioto Biosciences, a US biotech, in August this year, the company has expanded its global microbiome pipeline into brain diseases and continues to pioneer the market in order to transform into a global microbiome healthcare group capable of research, development and production. For more information, please refer to our website http://www.genomecom.co.kr.

 

About GEN-001

 

GEN-001 is an oral microbiome therapeutic candidate developed to have immune modulating activities, resulting in potential partnership with immune checkpoint inhibitors. GEN-001 consists a single-strain bacteria (Lactococcus lactis) isolated from gut of healthy human volunteers that has been shown to activate dendritic cells, macrophages and T cell response. In preclinical studies, GEN-001 has shown optimal safety margin and synergistic effects in combination with immune checkpoint inhibitors by enhancing the effect of suppressing the growth of both immune checkpoint inhibitor sensitive and resistant tumor models. A Phase 1/1b clinical trial is currently in progress in the US and Korea.

 

Avelumab Approved Indications

 

Avelumab (BAVENCIO®) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

 

Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

 

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

 

Avelumab Important Safety Information from the US FDA-Approved Label

 

The warnings and precautions for avelumab (BAVENCIO®) include immune-mediated adverse reactions (such as pneumonitis and hepatitis including fatal cases, colitis, endocrinopathies, nephritis, and other immune-mediated adverse reactions as a single agent or in combination with axitinib which can be severe and have included fatal cases), infusion-related reactions, hepatotoxicity in combination with axitinib, major adverse cardiovascular events (MACE) in combination with axitinib which can be severe and have included fatal cases, and embryo-fetal toxicity.

 

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO® monotherapy include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction peripheral edema, decreased appetite, urinary tract infection and rash. Common adverse reactions (reported in at least 20% of patients) in patients receiving BAVENCIO® in combination with axitinib include diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, palmar-plantar erythrodysesthesia, dysphonia, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, dyspnea, abdominal pain and headache. Grade 3-4 hematology laboratory value abnormalities reported in at least 10% of patients with Merkel cell carcinoma treated with BAVENCIO® monotherapy include lymphopenia; in patients receiving BAVENCIO® in combination with axitinib, grade 3-4 clinical chemistry abnormalities include blood triglyceride increased and lipase increased.

 

For full US Prescribing Information and Medication Guide for BAVENCIO®, please see http://www.BAVENCIO.com.

 

BAVENCIO® is a trademark of Merck KGaA, Darmstadt, Germany.

 

                             

 
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